Medical Devices

Manufacturing

  • Development and optimization of production methods for device manufacture
  • Development of strategy and approach to streamline manufacturing efforts
  • Composing and reviewing manufacturing documents, including:
    • Test protocols and reports
    • SOPs, batch records, and related GMP documents
    • Process Flowcharts
  • Risk assessments and gap analysis of manufacturing process
  • Tolerance/Specification development
  • Technical investigation of failures and rejects
  • Hands-on assistance during manufacturing start-up (person in plant)
  • Master planning, scheduling and tracking of manufacturing efforts
  • Assistance with Facility design
  • Writing and review of documents for global regulatory submissions
  • Long-term planning and process feasibility (Project Management)